The present invention generally relates to blood collection devices and more specifically to self-sealing, needle free blood collection devices.
Collecting blood from a patient, though a necessary and routine medical procedure, is often a difficult task, particularly in the case of children, small adults, and the elderly, who may have small or “rolling” veins. As a result, multiple needle punctures of the patient may be required to obtain proper access to a vein, causing distress to both the patient and the caregiver. Worse, this procedure may have to be repeated several times over the course of the patient's hospital stay to draw blood samples for prescribed tests or on-going patient monitoring.
To get blood from the patient into a vial, the conventional method is to employ a device that combines a needle holder with a blood collection vial. This device typically has a double-ended sharpened cannula with one sharpened end being unprotected for insertion into a vein of the patient's arm and the opposite, second, sharpened end being located within a flange used to receive a sealed blood vial. As the blood vial is pressed into the flange, the second sharpened end of the cannula pierces the blood vial's septum to initiate the flow of blood from the patient into the vial for collection. While this approach may be satisfactory for single-puncture applications where a one-time withdrawal or administration of fluids is to occur, the double-ended cannula and cannula holder device are not well-suited for multiple or long-term uses. Manipulation of the device when exchanging vials can be painful to a patient, and when one vial is disconnected so that another can replace it, the patient's blood may flow out the cannula in the meantime, causing contamination.
In order to address some of these concerns, as is now known and widely practiced in the art, an intravenous (referred to as “I.V.”) tubing set including a venipuncture needle (sharpened cannula), a length of plastic tubing extending from the needle, and a solution bag at the opposite end of the tubing have been used. The tubing may also include one or more valve ports along its length for access to the I.V. line. In use, the venipuncture needle is inserted into a patient's vein, just as with the typical blood collection device. However, once the I.V. line is placed in connection with the venipuncture needle, the needle can remain in position long-term, allowing blood to be withdrawn and medicines and other solutions to be administered intravenously on multiple occasions without having to repeatedly puncture the patient. In employing the typical I.V. tubing set, blood is often collected in the solution bag attached to the tubing or in a vacuumized blood collection vial through a valve port positioned along the tubing. Blood collection vials are typically manufactured with a partial vacuum within the vial and are sealed with a puncturable membrane that functions to maintain the partial vacuum within the vial yet allow access to the vial to collect blood. When the sealing membrane is punctured, the vial draws the patient's blood into the vial due to its partial vacuum. Because of the partial vacuum manufactured into blood collection vials, they are often referred to as being “vacuumized.”
Prior art valve ports often entail conventional female connectors so that extension sets or gas sampling lines, syringes, or other such medical devices can be connected to a patient's I.V. line. The conventional female connector is open or unsealed, so that upon disconnection of the medical device, any residual fluids within the connector could come into contact with the patient or caregiver, risking contamination. Because of this risk, self-sealing, needle-free female luer connectors have been developed and employed in the art such that, upon disconnection, the female connector seals itself and traps any residual fluids within the patient's I.V. line.
Where a venipuncture needle and tube are employed and blood is to be withdrawn through a valve port in the patient's I.V. line into a blood collection vial, the conventional double-ended needle cannula holders have still been employed to facilitate the transfer of blood through the valve port and into the vial. One of the valve ports in the patient's I.V. line may be configured with a pierceable septum so that the free end of the sharpened cannula can be inserted into the valve port through the septum, rather than directly into the patient, and the holder at the opposite end of the cannula can accept a blood collection vial as before. However, this method, though effective, is not as desirable because the use of the sharpened cannula for insertion into the valve port presents opportunities for inadvertent needle punctures and resulting contamination of the caregiver and patient.
Alternatively, because I.V. line valve ports may now also be configured with self-sealing female luer connectors, vial holders known in the art may be utilized having a single sharpened cannula extending within the holder for acceptance of the vial, while the opposite end is generally configured as a conventional open male connector (with no valve) for interfacing the female connector on the I.V. line. In this way, needle-free connection between the vial holder and the patient's I.V. line is achieved. However, because the male connector is open and unsealed, any residual blood in or about the connector will be exposed when the holder is disconnected from the I.V. female connector valve port after use. Further, the single-needle cannula, though shielded by the vial holder and the required piercing of the vial septum by the cannula still pose a risk of an inadvertent needle puncture or cross-contamination. Relatedly, the required handling of the vials, including the removal of a full vial and the replacement of an empty vial in the holder, may pose additional risks that could be avoided if the vial and holder were an integral, self-sealing blood collection unit.
Therefore, those skilled in the art have recognized a need for a needle free blood collection device that includes a self-sealing male luer connector that may be connected to a female luer connector for the safe and effective collection of blood without the risks associated with the use of sharpened needles and changing vials in a holder. Further, those skilled in the art have recognized a need for a self-sealing male luer connector that may be connected to a female luer connector that forms a part of a patient's I.V. line. Even further, there has been recognized a need for an integral self-sealing male luer connector with a blood collection vial under partial vacuum such that a blood sample may be taken with the integral device and that device may then be disconnected from a female connector and forwarded for analysis. The present invention fulfills these needs and others.